VITROS DAT Performance Verifier I recalled due to labeling issue
Ortho-Clinical Diagnostics is recalling 349 units of VITROS DAT Performance Verifier I because the storage labeling is incorrect, which may cause lower than expected test results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for a medical device with incorrect labeling that may lead to inaccurate test results, posing a risk of harm without reported injuries.
Plain-English summary
Ortho-Clinical Diagnostics is recalling 349 units of VITROS Chemistry Products DAT Performance Verifier I, an in vitro diagnostic device used for testing.
The recall is due to the product not meeting current storage labeling for unopened verifiers, which can cause customers to obtain lower than expected VITROS BENZ results. The device was distributed worldwide. The FDA has classified this as a Class II recall. Consumers should refer to the FDA recall notice or contact the manufacturer for further instructions.
The recalled product
- Product
- VITROS Chemistry Products DAT Performance Verifier I in vitro diagnostic
- Manufacturer
- Ortho-Clinical Diagnostics
- Affected units
- 349
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Catalog# 6802327 Lot# H5616
Distribution
Part of a larger recall action
This product is one of 5 recalled by Ortho-Clinical Diagnostics under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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